Cleared Traditional

HALO AP Dx

K232833 · Indica Labs, Inc. · Pathology

May 2024

Decision

237d

Days

Class 2

Risk

About This 510(k) Submission

K232833 is an FDA 510(k) clearance for the HALO AP Dx, a Whole Slide Imaging System (Class II — Special Controls, product code PSY), submitted by Indica Labs, Inc. (Albuquerque, US). The FDA issued a Cleared decision on May 7, 2024, 237 days after receiving the submission on September 13, 2023. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3700.

Submission Details

510(k) Number	K232833 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 13, 2023
Decision Date	May 07, 2024
Days to Decision	237 days
Submission Type	Traditional
Review Panel	Pathology (PA)
Summary	Summary PDF

Device Classification

Product Code	PSY — Whole Slide Imaging System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 864.3700
Definition	The Whole Slide Imaging System Is An Automated Digital Slide Creation, Viewing, And Management System Intended As An Aid To The Pathologist To Review And Interpret Digital Images Of Surgical Pathology Slides Prepared From Formalin-fixed, Paraffin-embedded (ffpe) Tissue. The System Generates Digital Images That Would Otherwise Be Appropriate For Manual Visualization By Conventional Brightfield Microscopy. The Whole Slide Imaging System Is Not Intended For Use With Slides Prepared From Frozen Tissue, Cytology, And Non-ffpe Hematopathology Specimens (e.g., Peripheral Blood Smear).